1. Field of the Invention
The present invention relates to packaging of sutures and, more particularly, to improved packages for sutures to improve loading and handling characteristics thereof.
2. Description of the Related Art
This invention relates to molded suture retainers and their use for packaging sutures, including nonabsorbable and synthetic absorbable sutures, to improve the out of package flexibility and handling characteristics of the sutures after storage. Sutures can be either monofilament or braided and are available in a wide variety of materials including cotton, silk, stainless steel, catgut, and dacron, nylon or other synthetic materials.
Synthetic absorbable sutures are typically formed using polymers and copolymers of glycolic acid (i.e., hydroxyacetic acid), the cyclic dimer of glycolic acid ("glycolide"), lactic acid, the cyclic dimer of lactic acid ("lactide") and related monomers, polydioxanone, polytrimethylene carbonate, polyalkylene glycol, polycaprolactone, their copolymers, etc.
Many types of packages for sutures are known in the art including those described in U.S. Pat. Nos. 2,917,878; 2,949,181; 2,965,225; 3,043,067; 3,143,209; 3,147,861; 3,163,288; 3,202,272; 3,221,873; 3,256,981; 3,280,971; 3,315,802; 3,319,782; 3,338,401; 3,357,549; 3,490,192; 3,613,879; 3,627,120; 3,642,126; 3,648,949; 3,8766,068; 3,939,969; 4,014,433; 4,069,912; 4,089,410; 4,135,623; 4,168,000; 4,249,656; 4,261,463; 4,284,194; 4,369,880; and, 4,549,649.
Nonabsorbable sutures may be packaged and/or sterilized using conventional techniques without concern for degradation of the suture material through hydrolysis. Synthetic absorbable sutures, in contrast, typically are packaged in moisture impervious foil laminate envelopes wherein the suture is wound in a FIG. 8 pattern on a paper retainer. Typical retainers of this type are shown in U.S. Pat. Nos. 4,131,195, 4,192,420, 4,249,656, 4,253,563 and 4,063,638.
Molded suture packages having narrow convoluted passageways configured to predetermine the coil of the suture are also known. For example, U.S. Pat. Nos. 3,338,401 and 3,490,192 disclose molded suture packages wherein one or more elongated sutures are retained in a coiled narrow passageway having a plurality of convolutions therein. These passageways are proportioned to accommodate an entire length of the suture end to end without folding. These passageways are typically molded into a plastic carrier material and define a small diameter hollow plastic tube. The patents also discuss the loading of sutures into the passageways using a vacuum. Molded retainers have been used to package some nonabsorbable sutures, but have not been adopted for widespread use in packaging sutures, particularly synthetic absorbable sutures.
Typical commercially available synthetic absorbable sutures are packaged under extremely dry conditions, and are relatively stiff and inflexible upon removal from the packaging. Such sutures exhibit "memory" which causes the suture to retain or resume the customary FIG. 8 or coiled shape assumed by sutures packaged in such a configuration in a cardboard or paper retainer. This effect is undesirable since the suture must be straightened prior to use. The figure 8 configuration has also been found to introduce undesirable kinks and binds in the suture. It is believed that the extremely dry conditions required for packaging prior synthetic absorbable sutures, together with the suture memory effect created by such packaging and the number and radius of curvature of the convolutions required to accommodate full length sutures may combine to make it difficult or impossible to withdraw the suture from such packaging without breaking the suture or detaching the needle from an armed suture. This is particularly believed to be true in the case of sutures having lengths in excess of 20 inches wherein the passageways must be compressed and convoluted in order to accommodate the suture end to end.
Therefore, it would be highly desirable to provide a molded suture retainer and method of loading same which permits the suture to be stored more efficiently without the introduction of kinks and bends.
Accordingly, it is one object of the invention to provide a molded suture retainer which permits easy installation, storage and removal of sutures without kinks and bends therein.
It is a further object of the present invention to provide a molded suture retainer and method of loading same which provides more efficient loading, storage and removal of long length sutures.
It is another object of the present invention to provide a molded suture retainer for efficiently storing surgical sutures fabricated from hydrolytically unstable polymers.
These and other highly desirable and unusual results are accomplished by the present invention in a molded suture retainer which permits the loading and efficient storage of sutures and easy removal without kinks and bends.
Objects and advantages of the invention are set forth in part herein and in part will be obvious herefrom, or may be learned by practice with the invention, which is realized and attained by means of the instrumentalities and combinations pointed out in the appended claims.
The invention consists of the novel parts, constructions, arrangements, combinations, steps and improvements herein shown and described.